Co-Amoxiclav 500/125mg Tablets
190 mm
190 mm
400 mm
What is in this leaflet:
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information
1. What Co-amoxiclav is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-amoxiclav 500/125 mg film-coated tablets
(AmoxiciUin/Clavulanic acid)
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Co-amoxiclav 500/125 mg film-coated tablets but it will be referred to as Co-amoxiclav in the rest of this leaflet.
Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (Clavulanic acid) stops this from happening.
Co-amoxiclav is used in adults and children to treat the following infections:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and joint infections.
2. What you need to know before you take Co-amoxiclav
Do not take Co-amoxiclav
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav (listed in section 6)
• if you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic
Do not take Co-amoxiclav if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine if you:
• have glandular fever
• are being treated for liver or kidney problems
• are not passing water regularly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Co-amoxiclav.
In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Co-amoxiclav or a different medicine.
Conditions you need to look out for
Co-amoxiclav can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You must look out for certain symptoms while you are taking Co-amoxiclav, to reduce the risk of any problems. See ‘Conditions you need to look out fof in section 4.
Blood and urine tests
If you are having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that you are taking Co-amoxiclav. This is because Co-amoxiclav can affect the results of these types of tests.
Other medicines and Co-amoxiclav
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• If you are taking allopurinol (used for gout) with Co-amoxiclav, it may be more likely that you will have an allergic skin reaction.
• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav.
• If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav then extra blood tests may be needed.
• Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
• Co-amoxiclav may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.
Pregnancy and breast-feeding and fertility
If you are pregnant, you think you might be pregnant or if you are breast-feeding, please tell your doctor or pharmacist. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Co-amoxiclav can have side effects and the symptoms may make you unfit to drive. Don’t drive or operate machinery unless you are feeling well.
3. How to take Co-amoxiclav
Always take Co-amoxiclav exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
The usual dose is one tablet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with Co-amoxiclav oral suspension or sachets. Co-amoxiclav tablets are not recommended.
Ask your doctor or pharmacist for advice when giving Co-amoxiclav tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
Patients with kidney and liver problems
• If you have kidney problems the dose might be changed.
A different strength or different medicine may be chosen by your doctor.
• If you have liver problems you may have more frequent blood tests to check your liver is working.
Method of administration
• Swallow the tablets whole with a glass of water at the start of a meal or slightly before.
• Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Co-amoxiclav for more than 2 weeks. If you still feel unwell you should go back to see the doctor.
If you take more Co-amoxiclav than you should
If you take too much Co-amoxiclav, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take the medicine carton or bottle to show the doctor.
If you forget to take Co-amoxiclav
• If you forget to take a dose take it as soon as you remember.
• You should not take the next dose too soon, but wait around 4 hours before taking the next dose.
If you stop taking Co-amoxiclav
Keep taking Co-amoxiclav until the treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the x infection to come back.
SAME SIZE ARTWOK 190 x 400 mm Front
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Co-amoxiclav can cause side effects, although not everybody gets them.
Conditions you need to look out for Allergic reactions:
• skin rash
• inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• collapse
Contact a doctor immediately if you get any of these symptoms and stop taking Co-amoxiclav.
Inflammation of large intestine:
• watery diarrhoea usually with blood and mucus
• stomach pain and/or fever
Contact your doctor as soon as possible for advice if you get these symptoms.
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:
- a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
- widespread red skin rash with small pus containing blisters (bullous exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis)
Contact a doctor immediately if you get any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Co-amoxiclav or who have kidney problems)
• black tongue which looks hairy
Side effects that may show up in your blood or urine tests:
• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine
Very common side effects (may affect more than 1 in 10 people)
• diarrhoea (in adults)
Common side effects (may affect up to 1 in 10 people)
• thrush (candida - a yeast infection of the vagina, mouth or skin folds), feeling sick (nausea), especially when taking high doses
- if affected take Co-amoxiclav before food
• vomiting
• diarrhoea (in children)
Rare side effects (may affect up to 1 in 1000 people)
• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme)
- If you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in your blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Co-amoxiclav
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 250C. Store in the original package.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Co-amoxiclav contains
• The active substances are amoxicillin and clavulanic acid.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid.
• The other ingredients are:
- Tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, butylhydroxytoluene (E321), talc and magnesium stearate.
- Film-coat: hypromellose, titanium dioxide (E171), talc, macrogol 400, isopropyl alcohol and purified water.
What Co-amoxiclav looks like and contents of the pack
• Co-amoxiclav tablets are white to off-white oval shaped, biconvex, film-coated tablets with “BL-625” debossed on one side of the tablet. They are packaged in blister packs of 10, 12, 14, 15, 16, 20, 21, 40 or 50 tablets, enclosed in a carton.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
E-mail: info@brisol-labs.co.uk
Co-amoxiclav 500/125mg film-coated tablets;
PL 17907/0483
This leaflet was last revised in March 2015
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above
Uncommon side effects (may affect up to 1 in 100 people)
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache
Uncommon side effects that may show up in your blood tests:
• increase in some substances (enzymes) produced by the liver
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SAME SIZE ARTWOK 190 x 400 mm Back